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16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects

Primary Purpose

Aging Problems, Pigmentation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cosmetic Formulations
Sponsored by
Avon Products, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging Problems focused on measuring cosmetic, ethnic skin, anti-aging, pigmentation

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Be a female in general good health, based on medical history reported by the subject;
  2. From thirty (30) to sixty-five (65) years of age, inclusive;
  3. Fitzpatrick skin types IV, V or VI;
  4. Have mild to moderate skin tone evenness (a score of 3-6);
  5. Willing to avoid excessive solar or UV exposure including: minimizing direct sun exposure and avoiding tanning beds and sunless tanning products for the duration of the study;
  6. Willing to cleanse the face and remove all facial and all eye make-up prior to (or upon arrival) every study visit;
  7. Willing to use no other topical products on the face for the duration of the study except the assigned test product and the subject's regular brand(s) of non-medicated make-up products that do not contain salicylic acid, benzoyl peroxide, AHA's, retinol, or their analogs or derivatives;
  8. Willing to refrain from using exfoliating products for the duration of the study;
  9. Not make any changes to her usual skin care regimen while participating in this study, other than those required by the study protocol;
  10. Willing and able to follow all study instructions and adhere to study restrictions;
  11. Read and sign an IRB approved informed consent form after the nature of the study has been fully explained and all questions have been answered by site staff;
  12. Female subjects determined to be of child-bearing potential must indicate that they are not pregnant and/or lactating, nor do they intend to become pregnant during their study participation;
  13. Female subjects determined to be of child-bearing potential must agree to practice a medically acceptable form of birth control during the study;

Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:

  • Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring)
  • Barrier methods of contraception (condom or diaphragm)
  • Intrauterine device or system (IUD/IUS)
  • Surgical sterilization (vasectomy, hysterectomy, tubal occlusion, uterine ablation)
  • Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence is not an acceptable method of contraception

Exclusion Criteria:

  1. Has participated in any other clinical facial use study within four (4) weeks from the start of the study;
  2. Has received any type of skin treatment or procedure in the past 3 (3) months including: chemical peels, microdermabrasion, injection of collagen or other filler, Botox® injections, or any treatment involving heat, light, or RF energy;
  3. Is currently under a physician's care for a medical problem that, in the opinion of the Investigator or his designee, could affect the subject's treatment response;
  4. Is nursing, pregnant, or planning a pregnancy during the course of this study;
  5. Has excessive facial hair, or scars which could interfere with study evaluation in the opinion of the Investigator;
  6. Is taking any prescription or over-the-counter medication that, in the opinion of the Investigator or his designee, could affect the subject's treatment response;
  7. Has any other condition that, in the opinion of the Investigator or his designee, could interfere with the subject's ability to use the treatment as instructed, alter treatment response, or affect their ability to complete the study.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Skin Tone Unevenness
    Using a 0-9 scale where 0= even tone and 9=severe blotchy hyperpigmentation. Subjects will be recruited with mild to moderate skin tone unevenness. The goal is to show improvements by dermatologist assessments and photography
    Skin Firming
    Using a non-invasive clinical instrument (Cutometer) skin elasticity will be measure of the facial cheek
    Skin Moisture
    Using a non-invasive clinical instrument (SkiCon) skin conductance will be measure of the facial cheek
    Skin Oiliness
    Using a non-invasive clinical instrument (Sebumeter) skin conductance will be measure of the facial cheek

    Secondary Outcome Measures

    Full Information

    First Posted
    December 3, 2021
    Last Updated
    December 3, 2021
    Sponsor
    Avon Products, Inc.
    Collaborators
    University of Cape Town, Groote Schuur Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05160103
    Brief Title
    16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects
    Official Title
    16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Avon Products, Inc.
    Collaborators
    University of Cape Town, Groote Schuur Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is to determine the efficacy of seven different formulations currently marketed and commercially available cosmetic products on skin tone evenness, post-inflammatory hyperpigmentation, and discrete pigmentation in females of Fitzpatrick skin types IV-VI.
    Detailed Description
    This is a single site, double-blind randomized, split face, efficacy study. All subjects will receive a cleanser, Day Cream/sunscreen, and two treatment products. The treatment products will be applied in a split face fashion including behind the ear. Local volunteer subjects will be enrolled such that a total of eighty-four (84) subjects will complete the study; with 24 subjects completing in each treatment. Each subject will receive a cleanser, Day Cream/sunscreen and two treatment products as per the randomization. Subjects will use the cleanser twice daily, Day Cream/sunscreen in the morning, and the treatment products as specified after cleansing in the evening, for a period of 16 weeks. Clinical assessments, non-invasive instrument measurements and photographs will be completed at baseline and weeks 4, 8, 12, and 16. Biopsies will be taken at baseline and Week 16.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aging Problems, Pigmentation
    Keywords
    cosmetic, ethnic skin, anti-aging, pigmentation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single site, randomized, seven treatments, split face, efficacy study
    Masking
    ParticipantInvestigator
    Masking Description
    Products Codes A-G
    Allocation
    Randomized
    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Cosmetic Formulations
    Intervention Description
    Topical emulsions containing anti-aging ingredients
    Primary Outcome Measure Information:
    Title
    Skin Tone Unevenness
    Description
    Using a 0-9 scale where 0= even tone and 9=severe blotchy hyperpigmentation. Subjects will be recruited with mild to moderate skin tone unevenness. The goal is to show improvements by dermatologist assessments and photography
    Time Frame
    Every 4 weeks up to 16 weeks
    Title
    Skin Firming
    Description
    Using a non-invasive clinical instrument (Cutometer) skin elasticity will be measure of the facial cheek
    Time Frame
    Every 4 weeks up to 16 weeks
    Title
    Skin Moisture
    Description
    Using a non-invasive clinical instrument (SkiCon) skin conductance will be measure of the facial cheek
    Time Frame
    Every 4 weeks up to 16 weeks
    Title
    Skin Oiliness
    Description
    Using a non-invasive clinical instrument (Sebumeter) skin conductance will be measure of the facial cheek
    Time Frame
    Every 4 weeks up to 16 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Self-identifying females
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Be a female in general good health, based on medical history reported by the subject; From thirty (30) to sixty-five (65) years of age, inclusive; Fitzpatrick skin types IV, V or VI; Have mild to moderate skin tone evenness (a score of 3-6); Willing to avoid excessive solar or UV exposure including: minimizing direct sun exposure and avoiding tanning beds and sunless tanning products for the duration of the study; Willing to cleanse the face and remove all facial and all eye make-up prior to (or upon arrival) every study visit; Willing to use no other topical products on the face for the duration of the study except the assigned test product and the subject's regular brand(s) of non-medicated make-up products that do not contain salicylic acid, benzoyl peroxide, AHA's, retinol, or their analogs or derivatives; Willing to refrain from using exfoliating products for the duration of the study; Not make any changes to her usual skin care regimen while participating in this study, other than those required by the study protocol; Willing and able to follow all study instructions and adhere to study restrictions; Read and sign an IRB approved informed consent form after the nature of the study has been fully explained and all questions have been answered by site staff; Female subjects determined to be of child-bearing potential must indicate that they are not pregnant and/or lactating, nor do they intend to become pregnant during their study participation; Female subjects determined to be of child-bearing potential must agree to practice a medically acceptable form of birth control during the study; Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include: Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring) Barrier methods of contraception (condom or diaphragm) Intrauterine device or system (IUD/IUS) Surgical sterilization (vasectomy, hysterectomy, tubal occlusion, uterine ablation) Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence is not an acceptable method of contraception Exclusion Criteria: Has participated in any other clinical facial use study within four (4) weeks from the start of the study; Has received any type of skin treatment or procedure in the past 3 (3) months including: chemical peels, microdermabrasion, injection of collagen or other filler, Botox® injections, or any treatment involving heat, light, or RF energy; Is currently under a physician's care for a medical problem that, in the opinion of the Investigator or his designee, could affect the subject's treatment response; Is nursing, pregnant, or planning a pregnancy during the course of this study; Has excessive facial hair, or scars which could interfere with study evaluation in the opinion of the Investigator; Is taking any prescription or over-the-counter medication that, in the opinion of the Investigator or his designee, could affect the subject's treatment response; Has any other condition that, in the opinion of the Investigator or his designee, could interfere with the subject's ability to use the treatment as instructed, alter treatment response, or affect their ability to complete the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Musonda Machona, MD
    Phone
    +27(0)634328862
    Email
    musondamachona@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nonhlanhla P Khumalo, PhD
    Phone
    +27(0)214043376
    Email
    n.khumalo@uct.ac.za
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ardeshir Bayat, PhD
    Organizational Affiliation
    Professor & Co-Director, University of Cape Town
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects

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